HealthyPhase 1NCT01774773
A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015)
A Phase 1 study testing Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg, Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg and Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg in people with Healthy, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases including pre-randomization (before drug administration) and postrandomization (after drug administration). Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg, Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg and Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smokers aged 20-44 at the time of informed consent,
- BMI is between 18.5 kg/m2 and below 25 kg/m2 at screening,
- Platelet count is between 120,000/ microliter and below 300,000/ microliter at screening and baseline
- Subjects and their partners can agree to use medically appropriate contraception through the study period
- Voluntarily provided written informed consent
- Willing and able to comply with the protocol
Who cannot join
- With a past or present history of arterial thrombosis, venous thrombosis or thrombophilia
- With a past history of clinically significant disease within 8 weeks before study drug administration or clinically significant infection within 4 weeks before study drug administration
- With a past surgical history that may affect the pharmacokinetics of E5501
- Suspected to have a clinically abnormal symptom or organ dysfunction that requires treatment based on the past history, complications, subjective and objective symptoms, vital signs and body weight, electrocardiograms or clinical laboratory results at screening or baseline
- QTcF greater than 450 ms (corrected for heart rate according to Fridericia's formula) category of the 12-lead electrocardiogram at screening or baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet
E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases including pre-randomization (before drug administration) and postrandomization (after drug administration).
- Conditions
- Healthy
- Being tested
- Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg, Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg, Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: E5501 5mg, then 20mg, then 40 mg, then 5mgDrug
The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days.
Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.
Group B: E5501 20mg, then 40mg, then 5 mg, then 5mgDrug
The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): one 5 mg tablet under fed conditions on treatment morning for 28 days.
Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.
Group C: E5501 40mg, then 5mg, then 20 mg, then 5mgDrug
The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days.
Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | E5501 5mg, then 20mg, then 40 mg, then 5mg Receives: Drug: Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg |
| Group B | Experimental | E5501 20mg, then 40mg, then 5 mg, then 5mg Receives: Drug: Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg |
| Group C | Experimental | E5501 40mg, then 5mg, then 20 mg, then 5mg Receives: Drug: Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] Under Fed Conditions
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] Under Fed Conditions
AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Pharmacokinetic Parameter: Time to Reach Maximum Observed Plasma Concentration (Tmax) Under Fed Conditions
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Pharmacokinetic Parameter: Plasma Decay Half-Life (t1/2) Under Fed Conditions
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fuminori Ohba, Study director, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774773
- Sponsor's protocol ID
- E5501-J081-015
- Status last verified
- Jan 2014
- First submitted
- 18 Jan 2013
- Last updated
- 3 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet
- ClinicalTrials.gov ID
- NCT01774773
- Acronym / sponsor ID
- E5501-J081-015
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases including pre-randomization (before drug administration) and postrandomization (after drug administration).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Group A: E5501 5mg, then 20mg, then 40 mg, then 5mgE5501 5mg, then 20mg, then 40 mg, then 5mg |
| Group B | Experimental | Drug: Group B: E5501 20mg, then 40mg, then 5 mg, then 5mgE5501 20mg, then 40mg, then 5 mg, then 5mg |
| Group C | Experimental | Drug: Group C: E5501 40mg, then 5mg, then 20 mg, then 5mgE5501 40mg, then 5mg, then 20 mg, then 5mg |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smokers aged 20-44 at the time of informed consent,
- BMI is between 18.5 kg/m2 and below 25 kg/m2 at screening,
- Platelet count is between 120,000/ microliter and below 300,000/ microliter at screening and baseline
- Subjects and their partners can agree to use medically appropriate contraception through the study period
- Voluntarily provided written informed consent
Key exclusion criteria (5 listed)
- With a past or present history of arterial thrombosis, venous thrombosis or thrombophilia
- With a past history of clinically significant disease within 8 weeks before study drug administration or clinically significant infection within 4 weeks before study drug administration
- With a past surgical history that may affect the pharmacokinetics of E5501
- Suspected to have a clinically abnormal symptom or organ dysfunction that requires treatment based on the past history, complications, subjective and objective symptoms, vital signs and body weight, electrocardiograms or clinical laboratory results at screening or baseline
- QTcF greater than 450 ms (corrected for heart rate according to Fridericia's formula) category of the 12-lead electrocardiogram at screening or baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: E5501 5mg, then 20mg, then 40 mg, then 5mgThe post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days. The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively. | Drug | Group A |
| Group B: E5501 20mg, then 40mg, then 5 mg, then 5mgThe post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days. The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively. | Drug | Group B |
| Group C: E5501 40mg, then 5mg, then 20 mg, then 5mgThe post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days. The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively. | Drug | Group C |
Primary outcome
Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] Under Fed Conditions
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] Under Fed Conditions
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Pharmacokinetic Parameter: Time to Reach Maximum Observed Plasma Concentration (Tmax) Under Fed Conditions
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Pharmacokinetic Parameter: Plasma Decay Half-Life (t1/2) Under Fed Conditions
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuminori Ohba study director
Eisai Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg, Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg and Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg in people with Healthy, run by Eisai Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions (time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.